Facility

SMISSON-CARTLEDGE BIOMEDICAL LLC

1 recall(s) on record — most severe on record: Class I.

Key facts

1recalls · worst Class I

2inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3006158088
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	487 Cherry Street Macon, GA, US 31201
Registration status	Active · expires 2026
Parent company	SMISSON-CARTLEDGE BIOMEDICAL LLC (owner-operator 9097032)
Brand names	ThermaCor 1200 Disposable Sets

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (3)

Warmer, Thermal, Infusion Fluid
Product code LGZ (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5725
Set, Administration, Intravascular
Product code FPA (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5440
Pump, Infusion
Product code FRN (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5725

Recalls & enforcement

Class ITerminated2021-02-18
Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids.

FDA inspections (2)

NAI2023-09-15
No Action Indicated · Compliance: Devices
NAI2018-02-28
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by SMISSON-CARTLEDGE BIOMEDICAL LLC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SMISSON-CARTLEDGE BIOMEDICAL LLC (FEI 3006158088) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006158088-smisson-cartledge-biomedical-llc/

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